HAEMOVIGILANCE ‘ a set of surveillance procedures covering the whole transfusion chain from the collection of blood and its components to the follow-up of its recipients, intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence & re-occurrence ’ Ms. Emma O’Riordan The Postgraduate Medical Education Haemovigilance, CNM2 ( Acting ) Service Ms. Bríd Doyle, Intern Teaching @ Cork University MSc. FAMLS. Hospital Haemovigilance Co-ordinator, Date: Thursday 28 th January 2016 ( Acting )
EU Blood Directive 98/EC/2002 The EU directive has been transposed into Irish law with full compliance with the legislation since November 2008. Organisations, including hospital, not complying with the directive could face fines or criminal charges Sets standards for quality and safety for collection, testing, processing, storage and distribution of human blood and blood components Specifies certain technical requirements for blood and blood components and for quality management systems, traceability and notification of adverse events & reactions
EU Blood Directive 98/EC/2002 Key articles : Article 10: Personnel “… personnel directly involved in collecting, testing, processing, storage and distribution of human blood and blood components shall be qualified to perform those tasks and be provided with timely, relevant and regularly updated training ’ Article 11: Quality Systems – “.. requires formal quality systems to be in place ” Article 12: Document Control – “… requires secure document control …...documentation must be stored for 30 years ” Article 14: Traceability - requires vein to vein traceability Article 15: Notification of SARs/SAEs – “.. mandatory notification of serious adverse reactions and events ”
Summary of the EU Blood Directives What is it? It’s an EU law. Why is it there? To ensure that the same high standards are to be met throughout EU. So if you need blood in Stockholm or Cyprus, it’s collection, processing, storage and distribution is treated to the same standard as in Ireland!
What the CUH expects of you SNBTS Blood Transfusion e-learning certification - certificate to be presented to Blood Bank CUH Blood component prescription Patient Information Leaflet Sampling and labelling the pre-transfusion specimen Familiarisation with the CUH/CUMH blood transfusion policies and procedures Recognising, managing and investigating suspected transfusion reactions ( will be covered in second presentation in February )
SNBTS Blood Transfusion e-learning certification “SNBTS better blood transfusion” www.learnbloodtransfusion.org.uk/ Print off Certificate and hand into Blood Bank
Prescription of Blood Components Four stages in prescription process Medical Responsibility: Decide on appropriate use of blood and blood components Justify the prescription using risk benefit analysis Informing the patient of the decision to transfuse Documentation of the prescription
Prescription of Blood Components Decision to transfuse Medical Responsibility Based on clear expectation of benefit Based on best available evidence. Benefits of the transfusion must outweigh the risks for appropriate transfusion. Refer to international guidelines on best practice with regard to transfusion Medical responsibility to inform yourselves of international guidelines National Blood Users Group Guidelines and BCSH guidelines
Prescription of Blood Components Justify the decision to transfuse Document reason for transfusion in patient ’ s health records e.g. “… Hb 7.2g/dl, shortness of breath, transfuse one unit … . ”
CUH Patient Information Leaflet Informing the Patient Medical Responsibility Patient Information Leaflet Document Transfusion Record (form 15/15A) Ask the patient to read it Discuss any concerns & worries Document discussion in the patient’s Health record Refusal
Blood Transfusion Prescription Medical Responsibility Complete Fully, Clearly, Legibly Date & Time of prescription Blood Component/Product Special Blood Requirements Prophylactic Drug Therapy Rate of Infusion Patient Information Leaflet Signature, MCRN, Bleep Audit Annual INAB &/or IMB Inspection
Blood Transfusion Prescription Indicate Clearly Complete Legibly
Overall Comparison of Blood Component Prescription Documentation 100% 90% 80% 70% 60% Sep-15 50% Feb-15 40% Jul-14 30% Mar-14 20% 10% 0% Date Component Reason Patient Info Special No.Units Prophylaxis Rate MCRN Prescrib. Id Leaflet Requirements
Special Blood Requirements 3 SAE’s ~ irradiation requirement not indicated in 2014 2 SAE’s ~ irradiation requirement not indicated in 2015 (1 Medical, 1 Surgical patient)
Sampling & Labelling the pre-transfusion specimen Approx. 5.5 % of specimens received into the CUH blood transfusion laboratory do not meet the MINIMUM labelling requirements • i.e. Patient’s Full Name, DOB & MRN plus YOUR signature on Request Form and Specimen Tube
Seasonal Variation 130 140 112 120 103 99 92 91 90 88 100 83 83 79 70 80 60 40 20 0 J F M A M J J A S 0 N D Jan – Dec 2012 15,912 blood transfusion specimens received (Group and Hold and Infant Blood Groups) 1,126 were incorrectly labelled 5.5% of samples were rejected in January – December 2015.
Blood Transfusion Request Form Medical Responsibility Must be hand written (no addressograph stickers!) Completed using the patient’s health records & confirm details on form correct Complete fully: Date, Transfusion history, Reason for request, etc NB!!! Special Blood Requirements !!! • 2 SAEs(2015) ~ irradiation requirement not indicated Blood Transfusion samples NOT processed through iCM Absolute minimum identifiers Patient’s Full Name Patient’s D.O.B. Patient’s M.R.N. Your Signature and Contact No.
Labelling the Pre-transfusion Specimen Medical Responsibility Specimen is labelled by hand immediately after taking the specimen and before leaving the bedside Blood Transfusion samples NOT processed through iCM Specimen tube must contain the following absolute minimum identifiers Patient’s Full Name Patient’s D.O.B. Patient’s M.R.N. Signature and Bleep No. Date, time, location etc
The Pre-transfusion Specimen Positive Patient Identification at the bedside Medical Responsibility Bring completed Request Form to the bedside Ask patient to state their aloud their name and D.O.B. ─ What is your name? ─ What is your date of birth? Check details given match Request Form and patient’s Hospital Identity Bracelet Check M.R.N. on Request Form matches patient’s Hospital Identity Bracelet Be extra vigilant checking the identity of the unconscious / compromised patient
Rate of mis-collected or mis-labelled samples is 1000-10,000-fold more frequent that the risk of viral infection (Dzik et al:2003). The risk of viral infection has decreased over the years The risk of ABO-incompatible transfusion due to sample Comparison of the magnitudes of the risks mislabeling or patient associated with blood transfusion. The misidentification has remained vertical lines represent log orders of magnitude (e.g. 1/10, 1/100, 1/1000 etc). consistent The horizontal blocks represent the range (Williamson et al :1999) (Contreras and de Silva:1994) (BCSH Guidelines:1999). of individual risk estimates (Dzik 2002)
Wrong Blood in Tube Events Occurring in CUH 1 WBIT event detected in January 2016 7 2015: 4 WBIT Events Detected 6 2014: 2 WBIT Events Detected 2013: 3 WBIT Events Detected 5 2010 2012: 7 WBIT Events Detected 2011 2011: 6 WBIT Events Detected 2012 4 2010: 3 WBIT Events Detected 2013 2014 3 2015 2 1 0
─ Sample received in Blood Bank on patient DL; noted incorrect DOB on sample. ( Grouped as A Rh POS ) ─ Doctor informed. Stated he didn’t take blood from patient DL at all. However, he had taken blood from patient MK. ─ Doctor left bedside with unlabeled sample and proceeded to label at the nurses station. He got distracted and used patient notes from DL. ─ Historical Blood Group on DL: AB Rh POS
CUH/CUMH Policies & Procedures Your responsibility to be familiar with the CUH/CUMH blood transfusion policies and procedures CUH/CUMH policies and procedures are only available electronically on the hospital wide Q- Pulse system Q-Pulse available at all ward based PCs Q-Pulse accessed through the Staff Directory ( Citrix ) on the desktop of all ward computers
Log On, select “Documents”, select “My Folders”, select “Haemovigilance”
CUH Notification of Suspected Transfusion Reaction (Back of Form 15/15A) Recognising, managing and investigating suspected transfusion reactions
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